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Article History

Received: 29 December 2020

Accepted: 28 August 2021

First Online: 8 September 2021

Change Date: 8 October 2021

Change Type: Update

Change Details: In the original publication a supplementary file was missing. The article has been updated to include it.

Declarations

:

: The final protocol, any amendments, and informed consent documentation were reviewed and approved by the Institutional Review Board(s) (IRB) and/or Independent Ethics Committee(s) (IEC) at each of the investigational centers participating in the study. Investigators were required to inform their IRBs or IECs of the study’s progress and occurrence of any serious and/or unexpected adverse events. This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation Good Clinical Practice Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial participants.

: A signed and dated informed consent was required before any screen procedures were done. The investigators explained the nature, purpose, and risks of the study to each subject. Each subject was informed that he/she could withdraw from the study at any time and for any reason. Each subject was given sufficient time to consider the implications of the study before deciding whether to participate. Subjects who chose to participate signed an informed consent document.

: Not applicable.

: MdlV, AbbVie, Genzyme, Lilly, Pfizer, and TRB Pharma (consulting fees); BMS, Gilead, Glaxo, Pfizer, and Roche (trial investigator); AbbVie, Genzyme, Janssen Lilly, and Pfizer (speaker); GGB, no disclosures to report; RMX, AbbVie, BMS, Janssen, Lilly, Novartis, Pfizer, Roche, and UCB (consulting fees, speaker); CP-T, Pfizer, Sanofi, Roche, Eli Lilly, AbbVie, UCB, and BMS (consulting fees and speaker); AES, AES is an employee of Syneos Health and was contracted by Pfizer to provide statistical support for the development of this paper; RDP, RDP was an employee of Pfizer at the time of data generation and manuscript development and own stock in Pfizer; GS, CB, KS, BV, Pfizer (stock options, employment).